Surgical tool

ABSTRACT

A tunneling device for creating a pathway in subcutaneous tissue of a person&#39;s body. The tunneling device includes a member having two ends, where each of the ends defines an insertion surface that facilitates the insertion of the ends into the subcutaneous tissue of the person&#39;s body. The tunneling device includes an interchangeable handle connectable to each of the ends. The handle defines a grasping surface and an opening. The opening is configured to receive either of the ends. The grasping surface enables a user to securely hold the handle with one hand to forcibly move the member through the subcutaneous tissue of the person&#39;s body to create the pathway in the subcutaneous tissue, and pull a cable of an implant device through the created pathway.

BACKGROUND OF THE INVENTION

Thousands of heart patients who suffer from severe heart failure couldbenefit from a heart transplant. However, because of a shortage of donorhearts, most of these patients face a shortened life span characterizedby frequent hospitalizations, severe physical disability, and death fromcongestive failure or cardiogenic shock.

One medical device developed to aid these heart patients is a heart pumpsuch as a left ventricular assist device which enables heart failurepatients to return to prolonged and productive lives. A left ventricularassist device (“LVAD”) is a battery-operated, mechanical pump-typedevice that is surgically implanted. It helps maintain the pumpingability of a heart that cannot effectively work on its own.

A LVAD typically includes an electrical cable which is hardwired intothe LVAD and routed through a patient's body to an external controllerand battery. The surgical procedure of creating a channel or “tunnel”for routing the electrical cable through the body is commonly called“tunneling.”

The “tunneling” procedure is an invasive procedure that can lead toinfection. Therefore, to minimize the risk of infection and to provide asecure mechanical attachment between the electrical cable and thesurrounding tissue, the tunneling channel or path is typically madesmaller in size than the electrical connector attached at an end of theelectrical cable. The electrical connector is the part of the electricalcable that plugs into or engages the external controller. Usually, theelectrical connector is larger in size than the flexible body portion ofthe electrical cable. As a result, the force required to physically pullthe electrical cable through a patient's body is relatively high.

The surgical procedures for creating a tunneling channel or path in apatient's body varies widely. In one procedure, commonly called theoutside-in procedure, the tunneling path is created by a tunneling tool,which starts forming the tunnel on the outside of the patient's body.The tunnel goes through the abdominal cavity and up into the thoraciccavity near the LVAD and heart. After the tunnel or pathway is made inthe patient's body, the electrical cable is tied to the tunneling toolby a suture or other means. The electrical cable is then dragged orpulled back through the tunneling path using the tunneling tool until asuitable length of the electrical cable extends from the patient's bodyto connect the electrical cable to the external controller.

In another procedure, commonly called the inside-out procedure, thetunneling path is started from the thoracic cavity inside of thepatient's body and continues out through the patient's abdomen and skinto outside of the patient's body. The electrical cable is tied orotherwise connected to the end of the tunneling tool inside the body andpulled through the path to outside the body.

Both of the tunneling procedures described above and other similarprocedures employ a relatively high force to pull or drag the electricalcable through the tunnel or path formed in the patient's body. The highstress on the tissues of the body cause trauma to the issues and couldlead to complications, infection and extended recovery time forpatients.

Additionally, depending on which procedure is used, the design of thetunneling tool may be suitable for one procedure such as the outside-inprocedure, but not suitable or usable for another procedure, such as theinside-out procedure.

Accordingly, there is a need for a surgical tool which is adaptable tobe used for different tunneling procedures, which is easy to manipulateand use during a tunneling procedure and which minimizes the stress onthe body and the risk of infection during the procedure.

SUMMARY OF THE INVENTION

The present invention is directed to a surgical tool and, morespecifically, to a surgical tunneling device for creating a pathway inthe subcutaneous tissue of the body which is easy to use and adaptablefor use in different tunneling procedures.

One embodiment of the present invention provides a tunneling device thatincludes a malleable member having two ends, where each of the endsdefines an insertion surface that facilitates the insertion of the endsinto the subcutaneous tissue of the person's body. The tunneling deviceincludes an interchangeable handle connectable to each of the ends. Thehandle defines a grasping surface and an opening. The opening isconfigured to receive either of the ends. The grasping surface enables auser to securely hold the handle with one hand to forcibly move themalleable member through the subcutaneous tissue of the person's body tocreate the pathway in the subcutaneous tissue, and pull a cable of animplant device through the created pathway.

In an embodiment, the tunneling device includes a tip removablyconnected to at least one of the ends. The tip defines an insertionsurface.

In an embodiment, the tunneling device includes a tip removablyconnected to each of the ends. The tips respectively defining theinsertion surface, where at least a portion of each of the ends definesa plurality of threads, and where each of the tips is threadinglyengaged with one of the ends of the malleable member.

In an embodiment, the insertion surface defined by at least one of theends is a tapered surface.

In an embodiment, the insertion surface defined by each of the ends is atapered surface.

In an embodiment, the tunneling device includes a coupler removablyconnected to one of the ends of the member. The coupler is adapted tocouple the malleable member to an end of the cable.

In an embodiment, the handle includes an actuator, where the actuator isoperable to cause the handle to engage with or disengage from one of theends.

In an embodiment, the handle includes a shaft and a spring positionedbetween the shaft and the actuator. The actuator is operable to compressthe spring and cause the shaft to move to a position where one of theends of the malleable member is insertable into or releasable from thehandle.

Another embodiment provides a tunneling system for creating a pathway insubcutaneous tissue of a person's body. The tunneling system includes amalleable member having a first end and a second end. Each of the endsdefines an insertion surface that facilitates the insertion of the firstand second ends into the subcutaneous tissue of the person's body. Thetunneling device includes an interchangeable handle connectable to eachof the first and second ends. The handle defines a grasping surface andan opening. The opening is configured to receive either of the first andsecond ends and the grasping surface enables a user to securely hold thehandle with one hand. The tunneling system also includes a coupleroperable to join one of the first and second ends of the malleablemember and an end of a cable of an implant device to secure themalleable member and the cable together. The handle is operable toenable a user to forcibly move the malleable member through thesubcutaneous tissue of the person's body to create the pathway in thesubcutaneous tissue and enable the user to pull the cable of the implantdevice through the created pathway.

In an embodiment, the handle includes a post and a spring positionedbetween the post and the actuator. The post has a first diameter and asecond smaller diameter. The post is initially positioned adjacent tothe first end of the malleable member inserted in the handle to preventthe first end from being removed from the handle. The spring biases thepost inwardly to cause the second diameter of the post to be positionedadjacent to the first end of the malleable member to enable the firstend of the malleable member to be removed from the handle.

In an embodiment, the insertion surface of at least one of the first andsecond ends is a tapered surface.

In an embodiment, the insertion surface of each of the first and secondends is a tapered surface.

In an embodiment, the tunneling system includes a removable tip attachedto each of the first and second ends, where the removable tipsrespectively define the insertion surface described above.

In an embodiment, the insertion surface of at least one of the tips is atapered surface.

In an embodiment, the insertion surface of each of the tips is a taperedsurface.

In an embodiment, at least a portion of each of the tips defines aplurality of threads, where each of the tips is threadingly engaged withone of the ends of the member.

In an embodiment, the coupler includes a plurality of connectors. Afirst connector of the plurality of connectors is operable to secure thecoupler to the end of the cable and a second connector of the pluralityof connectors is operable to secure one of the first and second ends ofthe malleable member to the coupler.

Another embodiment provides a method of forming a pathway insubcutaneous tissue of a person's body. The method includes providing amalleable member having two ends, where each of the ends is insertableinto the subcutaneous tissue of the person's body. The method includesproviding a handle connectable to each of the ends of the member. Thehandle including an actuator operable to cause the handle to be engagedwith and disengaged from one of the ends of the member. The methodincludes activating the actuator, connecting the handle to one of theends of the malleable member and inserting the other of the ends intothe subcutaneous tissue of the person's body. The method includes movingthe other of the ends through the subcutaneous tissue of the person'sbody to create the pathway in the tissue of the body and connecting acable of a medical device implanted in the body to the other of theends. The method includes moving the cable through the pathway createdin the body using the handle.

In an embodiment, the method includes connecting a coupler to one of theends of the malleable member and to an end of the cable.

In an embodiment, the method includes connecting a removable tip to eachof the ends. Each of the removable tips defining an insertion surface tofacilitate the movement of the tips through the subcutaneous tissue ofthe body.

It is therefore an advantage of the present invention to provide asurgical tunneling device which enhances the efficiency of a surgicalprocedure.

Another advantage of the present invention is to provide a surgicaltunneling device which is adaptable to be used for different tunnelingprocedures.

Other objects, features and advantages of the invention will be apparentfrom the following detailed disclosure, taken in conjunction with theaccompanying sheets of drawings, wherein like numerals refer to likeparts, elements, components, steps and processes.

DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of one embodiment of the surgical tool ofthe present invention.

FIG. 2 is a fragmentary exploded view of FIG. 1.

FIG. 3 is an exploded view of the handle shown in FIG. 1.

FIG. 4 is a top view of the surgical tool of FIG. 1 where certain partsof the handle and an end of the flexible malleable member are shown inphantom.

FIG. 4A is a cross section view taken substantially along line 4A-4A ofFIG. 4.

FIG. 4B is an enlarged fragmentary view of an end of the surgical toolshown in FIG. 4A.

FIG. 4C is a fragmentary exploded view of an end of the surgical toolshown in FIG. 4A.

FIG. 5A is a partial cut away top view of the surgical tool of FIG. 1illustrating an end of the flexible malleable member engaged with thehandle.

FIG. 5B is a partial cut away top view of the surgical tool of FIG. 1illustrating the end of the flexible malleable member disengaged fromthe handle.

FIG. 6A is a cross-section view taken along line 6A-6A in FIG. 5Aillustrating the handle engaged with the end of the malleable member.

FIG. 6B is a cross-section view take substantially along line 6B-6B inFIG. 5B illustrating the handle disengaged from the end of the malleablemember.

FIG. 7A is a partial side view of the surgical tool of FIG. 1 and anelectrical cable illustrating an end of the flexible malleable member ofthe surgical tool disengaged from an end of the electrical cable.

FIG. 7B is a partial side view of the surgical tool of FIG. 1 and anelectrical cable illustrating an end of the flexible malleable member ofthe surgical tool engaged with the end of the electrical cable.

FIG. 8 is a side view of another embodiment of the surgical tool of thepresent invention.

FIG. 9A is an enlarged side view of one end of the surgical tool shownin FIG. 8.

FIG. 9A is an enlarged top view of one end of the surgical tool shown inFIG. 9A.

FIG. 10A is an enlarged side view of another end of the surgical toolshown in FIG. 8.

FIG. 10B is an enlarged top view of the end of the surgical tool shownin FIG. 10A.

FIG. 11 is a bottom view of the handle according to one embodiment ofthe present invention.

FIG. 12A is an enlarged side view of the cable coupling device accordingto one embodiment of the present invention.

FIG. 12B is a side view of the cable coupling device shown in FIG. 12A.

FIG. 12C is an enlarged, cross-sectional view of the cable couplingdevice taken along line A-A in FIG. 12B.

FIG. 12D is a cross-section view taken along line H-H in FIG. 12C.

DETAILED DESCRIPTION

The present invention is directed to a surgical tool, and morespecifically, to a tunneling device which creates a pathway in thesubcutaneous tissue of a person's body for routing cables of an implantdevice outside of the person's body to allow the communication with anddelivery of power to the implant device.

Referring now to the figures, the tunneling device 100 of the presentinvention includes a flexible or malleable shaft or malleable member 102which is semi-rigid and bendable to curve or bend through the tissue ofa person's body. The malleable member is made of a bendable or flexiblematerial such as 6061 anodized aluminum or any other suitable materialor combination of materials. The malleable member 102 may be anysuitable size in shape and is generally sized to be slightly smallerthan the size or diameter of a cable or wire connected to an implantdevice, which is routed through a person's body. In one embodiment,shown in FIG. 8, the malleable member 202 is made of alternatingsections of varying diameters, including at least a first section 202 ahaving a diameter greater than an adjoining second section 202 b. Thetwo sections 202 a and 202 b may alternate along the length of themalleable member 202. According to this embodiment, the larger diametersections, such as section 202 a, may be used for ease of gripping by theuser, whereas the narrower sections, such as section 202 b, may be bent.This arrangement of alternating diameters provides sufficientflexibility to the tunneling device to enable the user to bend the toolinto different shapes as necessary to facilitate the creation of apathway through the subcutaneous tissue of the body.

In the illustrated embodiment, the malleable member 102 includes twoends 104 a and 104 b. In one embodiment, each of the ends 104 a and 104b are identical and define an insertion surface which is angled ortapered to facilitate the insertion of the ends into tissue of aperson's body.

In one embodiment, a tapered or bullet-like interchangeable removabletip 106 is connected to at least one of the ends 104 a and 104 b. Inanother embodiment, the removable tip 105 is connected to each of theends 104 a and 104 b. Each tip 105 includes an angled or tapered surface106 which defines the insertion surface to facilitate the insertion orpiercing and movement of the tips through the subcutaneous tissue of thebody. In the illustrated embodiment, the tips 105 are made of stainlesssteel. It should be appreciated that the tips may be made of anysuitable material or materials.

Referring to FIGS. 4B and 4C, each end 104 a and 104 b includes athreaded portion 108 which is threadingly engaged with correspondingthreads 142 formed on a portion of the tips 106. Specifically, a capscrew 142 is inserted into an end of the removable tip. The cap screw142 includes a threaded portion 143 and a head 144. The threaded portion143 extends through an opening defined by rotating collar 138 and isscrewed into the corresponding threaded portions 108 of one or both ends104 a and 104 b to hold or secure the collar 138 to the ends 104 a and104 b. The cap screw is twisted or screwed into the end of the malleablemember 102 so that a gap, G, is formed between the bottom of the head144 of the cap screw 142 and bottom inside surfaces of the collar 138 asshown in FIG. 4B to allow the collar 138 to freely move or rotate withrespect to the end of the malleable member. It should be appreciatedthat the gap, G, may be any suitable size to allow free rotation of thecollar.

The tip 105 defines threads 147 and is screwed into correspondingthreads defined by the collar 138 to enable the tips 105 to be securedto the ends 104 a and 104 b of the malleable member 102. In one example,the tip 105 is screwed into the collar 138 by rotating the tip andholding the collar in place. In another example, the tip 105 is held inplace while a user grasps or grips beveled surfaces 140 of the collar138 and rotates the collar 138 using their fingers or a tool to securethe collar 138 to the cap screw 142. It should be appreciated that thetip 105 may be secured to the collar 138 or the ends 104 a and 104 busing any suitable connector or connection method.

Referring to FIGS. 3-6B, the handle or grip 112 is connectable to eachend 104 a and 104 b and more specifically, to each tip 106 connected tothe ends of the malleable member 102. The handle 112 includes an input,button or actuator 114, a spring 116 positioned adjacent to the actuatorand an engagement shaft or post 118 which is positioned adjacent to thespring 116. The handle defines an opening 120 which is positioned on anaxis that is transverse to the axis defined by the engagement shaft orpost. As shown in FIG. 3, the handle defines end openings 113 a and 113b and channel 113 c. In one embodiment, the handle 112 is made of 6061anodized aluminum. It should be appreciated that the handle may be madeof any suitable material or materials.

The channel 113 c is an elongated opening which extends the length ofthe handle and includes an axis which is parallel to the axis of thehandle. The channel 113 c is positioned off-center as shown in FIG. 4.It should be appreciated that the channel 113 c may extend along thecenter of the handle or along any suitable position on the handle. Inthe illustrated embodiment, the channel 113 c includes a central portionor area 123 a having a first diameter and end portions or areas 123 beach having a second larger diameter than the first diameter. In theillustrated embodiment, the diameters of end portions 123 b are thesame. In another embodiment, the diameters of the end portions 123 b aredifferent. In the illustrated embodiment, the end portions 123 b eachdefine a shoulder 125. Specifically, as shown in FIG. 4, one end portiondefines shoulder 125 a and the opposing end portion defines shoulder 125b.

FIGS. 3 and 4 illustrate the assembly of the handle 112. The button 114and post 118 are connected together. In one embodiment, the button 114and post 118 are separate parts which are connected together using anysuitable connector or connection method. In another embodiment, thebutton 114 and post 118 are integrally formed. In the illustratedembodiment, the post 118 is inserted through spring 116 and into the endopening 113 a. The post 118 is inserted through channel 113 c and issecured in place by cap 115 which is connected to an end of post 118.The cap 115 includes a threaded portion or post 121 which is threadinglyengaged with the end of post 118 as shown in FIG. 4. The spring 116 ispositioned between the button 114 and shoulder 125 a. Shoulder 125 aprovides a bearing surface for spring 116 so that spring 116 compresseswhen button 114 is pushed or pressed inwardly and expands when button114 is released or moves outwardly away from housing 117. Shoulder 125 bacts as a stop to prevent cap 115 from moving inwardly past apredetermined distance in housing 117. The position of shoulder 125 bdetermines the distance that button 114 extends from housing 117.

In the illustrated embodiment, the post 118 includes a first diameter119 a and a second diameter 119 b. In one embodiment, the first diameteris larger than the second diameter. It should be appreciated that thepost may have any suitable number of diameters and the diameters may bethe same or different. The handle further defines a grasping or holdingsurface 117 which is grasped by a user's hand to forcibly push or pullthe malleable member 102.

Referring to FIGS. 4, 4A, 4B, 4C, 5A, 5B, 6A and 6B, the opening 120 isadapted to receive one of the ends of the malleable member 102. The endand more specifically, a designated length of the tip 106 connected tothe end, is inserted into the opening 120. Once the tip 106 is insertedinto the opening 120 of the handle 112, the actuator or button 114 isreleased and the spring 116 biases the actuator 114 outwardly away fromthe handle 112. This causes the engagement shaft or post 118 to move inthe same direction as the actuator and causes the first diameter 119 aof the shaft or post to engage the groove 110 defined by the tip 106connected to the malleable member 102. The first diameter 119 a of theengagement shaft or post 118 engages the groove 110 defined by the tip106 in such a way that the tip 106 of the malleable member 102 cannot bepulled out of the opening 120 defined by the handle 112. As a result,the end 104 a and more specifically, the tip 106 of the malleable member102 is secured to the handle 112. To release the tip 106 from the handle112, the button or actuator 114 is activated or pressed to cause thespring 116 to bias the post 118 inwardly within the handle 112. Thiscauses the smaller second diameter section 119 b of the post 118 to bepositioned over the tip 106 of the malleable member 102. Because thesmaller second diameter 119 b of the post 118 does not engage the groove110, the tip 106 of the malleable member 102 is free to move outwardlyaway from the opening 120 of the handle 112 to be released or removedfrom the handle. When the end 104 a is removed from the handle 112, thebutton 114 is deactivated or released.

Referring now to FIGS. 7A and 7B, a cap, coupler or coupling device 122is connected to an end 126 of a cable such as an electrical cableassociated with an implant device inserted in a person's body to enableone of the tips 106 of the malleable member 102 to be connected orcoupled to the cable 124 to move, pull or push the cable through atunnel or pathway created by the tunneling device 100 in the body and tominimize or prevent tissues and other contaminants from accumulating onan end of the cable. The coupler 122 includes an angled or taperedportion 128 which defines an opening 132 to receive the end 104 b of themalleable member 102. The coupler 122 also includes a straight portionor bottom portion 130 which includes a set screw 134. The set screw 134is turned or tightened after the coupler 122 is inserted on the end 126of the cable 124 to secure the coupler to the cable. The end 104 b ofthe malleable member 102 is inserted through the opening 132 defined bythe coupler and is secured by a set screw 136 threadingly connected toan inside surface at the tapered portion 128 of the coupler. The setscrew 136 is turned and tightened to engage the set screw 136 with thegroove 110 formed or defined by the tip 106 of the malleable member 102to secure the malleable member 102 to the coupler 122. Once secured, thetunneling device 100 can be used to move, push or pull cable 124 througha tunnel path formed in the tissue of the body using the tunnelingdevice 100.

In operation, the tunneling device 100 of the present invention may beused regardless of the surgical procedure employed to create the tunnelor pathway in the tissue of a person's body. For example, the tunnelingdevice 100 may be used to form a tunneled pathway for an inside-outprocedure or for an outside-in procedure, as described above. In theoutside-in procedure, an end 104 a or 104 b of the malleable member 102is inserted into the tissue of a patient's body. The handle 112 is theninserted on the end 104 a or 104 b of the malleable member 102 that isnot inserted into the tissue of the body by pressing or activating thebutton 114 on the handle 112 and inserting the end of the malleablemember 102 into the opening 120 defined by the handle 112. The button114 is released to secure the handle 112 to the end of the malleablemember 102 as described above. The handle 112 is attached to an end 104a or 104 b, and more specifically, one of the tips 106 of the malleablemember 102 using a single hand which saves time during the surgicalprocedure.

When the handle 112 is secured to the malleable member 102, a userapplies a force to the handle 112 to push the handle 112 inwardlytowards the body to cause the inserted end 104 a or 104 b, and morespecifically, the tip 106 of the malleable member 102 to move throughthe tissue of the body. Once the inserted end of the malleable member102 reaches the thoracic cavity, the cable 124 of the implant device(not shown) such as a blood pump, is connected to the end of themalleable member 102 using the coupler 122 as described above. When thecable 124 is coupled to the malleable member 102 of the tunneling device100, the user holds onto the grasping surface 117 of the handle andpulls the handle away from the body to correspondingly pull the insertedend 104 a or 104 b, or tip 106 of the malleable member 102 and thecoupled cable 124 through the tunneled pathway. The cable 124 is pulledthrough the tunneled pathway by the tunneling device 100 until the cableis pulled a sufficient distance out of the patient's body so that thecable can be connected to a suitable controller, battery or the like.

In an inside-out procedure, one of the tips 106 of the malleable member102 Is inserted into the tissue near the thoracic cavity by the heart.The handle 112 is secured to the opposite end or tip of the malleablemember (i.e., the end or tip not inserted in the tissue), as describedabove. The handle 112 is then pushed or forced inwardly until theinserted end or tip of the malleable member 102 exits the body throughthe skin. The handle 112 is then removed by pressing or activating thebutton 114 to release the handle from the opposite end or tip of themalleable member 102. The handle 112 is then connected on the other endof the malleable member 102 (i.e., the inserted end) by pressing thebutton 114 and inserting that end or tip of the malleable member 102into the opening 120 defined by the handle 112. The present inventiontherefore enables the tunneling device 100 to be used for any surgicaltunneling procedure to create a tunnel or pathway in the patient's body.In this procedure, the cable 124 is coupled to the malleable member nearthe thoracic cavity, and the cable 124 is pulled through the body bypulling on the handle as described above. The tunneling device 100 ofthe present invention is adaptable to be used in any surgical procedurefor creating a tunnel or pathway in the tissue of the body. Thetunneling device 100 of the present invention also enables a user toemploy a one-handed operation which saves valuable time during asurgical procedure.

In another embodiment, as shown in FIG. 8, each of the ends 204 a and204 b is different. One end 204 b defines an insertion end which has atapered shape, which may be substantially conical, to facilitate theinsertion of the end 204 b into and through the subcutaneous tissue ofthe body. In one embodiment, the tapered outer surface of a conical endmay define an angle of substantially 30 degrees. The tip of a conicalend may have a radius of 0.020 inches. The other end 204 a defines anattachment portion or configuration for engaging and fastening thehandle 212, shown in FIG. 11 According to one embodiment, the ends 204 aand 204 b are formed integrally with the malleable member 202, althoughother means of defining penetrating and attachment portions of thetunneling tool are within the scope of the present invention.

The attachment end 204 a may be generally cylindrical in shape and isshown in FIGS. 9A and 9B. The attachment end 204 a includes a narrow tip206 at a distal end thereof. In one embodiment, the tip 206 has alongitudinal length of about 0.12 inches. Adjacent the tip is anengagement section 208, which may be generally cylindrical, with theexception of two flat peripheral surfaces 213 and 214 which are formedon the outer surface of the attachment end 204 a so that the flatsurfaces 213 and 214 are disposed in substantially parallel planes onopposite sides of the attachment end 204 a. The flat surfaces 213 and214 do not extend the entire length of the engagement section 208, sothat a lip 216 remains at an end opposite the tip 206. A tapered ortruncated portion 207 is formed between the tip 206 and the flatsurfaces 213 and 214. In one embodiment, the taper portion 207 definesan angle of about 60 degrees to the longitudinal axis of the attachmentend 204 a. As shown in FIGS. 9A and 9B, a locking section 210 has areduced diameter compared to the overall diameter of the engagementsection 208 and the adjacent diameter of the malleable member 202. Thelocking section 210 will be used to lock the handle 212 onto thetunneling device 200 and also to lock a coupling device 250 onto thetunneling device 200, as will be described herein.

The flat surfaces 213 and 214 of the engagement section 208 enable theattachment end 204 a to engage the handle 212 (FIG. 11), so that thehandle 212 may be used to turn the tunneling device 200, as needed. Inparticular, as shown in FIG. 11, the handle 212 includes anear-elliptical hole 220 formed in a side thereof for receiving theattachment end 204 a of the tunneling device 200. The shape of thereceiving hole 220 is such that it includes two opposing linear sections228 and 229 which are connected by semi-circular segments 232 and 233 toform a generally elliptical shape. The linear sections 228 and 229 matewith the flat surfaces 213 and 214 which are formed in the engagementsection 208 of the attachment end 204 a. According to this construction,the attachment end 204 a may be inserted in the receiving hole 220 ofthe handle 212 such that when the handle 212 is rotated, the malleablemember 202 rotates in unison therewith and is unable to rotateindependently with respect to the handle 212. The handle 212 engages andlocks onto the attachment end 204 a of the tunneling device 200 in thesame manner as described above in connection with FIGS. 5A and 5B.According to this embodiment, the first diameter 119 a of the post 118engages the locking section 210 of the attachment end 204 a in such away that the attachment end 204 a cannot be pulled out of the opening220 formed in the handle 212, as described herein. The handle 212 isreleased from the tunneling device 200 in the same manner as describedin connection with FIG. 6B, wherein the smaller second diameter 119 b ofthe post 118, engages the locking section 210.

The insertion end 204 b may be generally conical in shape as shown inFIG. 10A. The insertion end 204 b includes a conical tip 225 whichextends from the end of the insertion end 204 b to the reduced diameter,locking section 226. The conical portion of the tip 205 may have a taperof about 30 degrees to the longitudinal axis of the tip 205. Theinsertion end 204 b is conical in shape so as to facilitate insertion ofthe tunneling member 200 into the subcutaneous tissue of the body.However, the conical tip 225 of the insertion end 204 b also has twoflat surfaces 223 and 224 which are cut from the conical tip 225 so thatthe flat surfaces 223 and 224 are disposed in parallel planes onopposite sides of the insertion end 204 b, so that the insertion end 204b also may be used with the handle 212. The flat surfaces 223 and 224 donot extend the entire length of the conical tip 225, so that a lip 227remains at an end opposite the tip 225. As shown in FIGS. 10A and 10B,the locking section 226 has a reduced diameter compared to the adjacentdiameter of the malleable member 202. The locking section 226 will beused to lock the handle 212 onto the tunneling device 200 and also tolock the coupling device 250 onto the tunneling device 200, as describedherein.

The tunneling device 200, including the attachment end 204 a and theinsertion end 204 b may be made of aluminum or any other suitablematerial.

An alternate embodiment 250 of the coupling device 122 of FIGS. 7A and7B is illustrated in FIGS. 12A through 12D. The coupling device 250 issimilar to the coupling device 122 shown in FIGS. 7A and 7B. Thecoupling device 250 includes a first tapered portion 252 and a secondtapered portion 254 at an end thereof. In one embodiment, the externaltaper angle 252 is about 15 degrees to the longitudinal axis of thecoupling device. The second tapered portion 254 may include a series offour equally-spaced slits 272 extending from a distal end 280 of thecoupling device 250 toward the opposite end of the second taperedportion 254. The slits 272 separate the second tapered portion 254 intofour prongs 255, each of which has a generally arc shape, as shown inFIG. 12B. The inner surface of each prong 255 includes a projection 260extending inward. To engage the coupling device 250 with the malleablemember 202, one end 204 a or 204 b of the tunneling device 200 isinserted into the open distal end 280 of the coupling device 250 alongthe inside surface of each of the prongs 255. As the end 204 a or 204 bin inserted, the projections 260 abut the engagement section 208 (FIG.9A) or conical tip 225 (FIG. 10B) and are pressed apart by the taperedsections 207 or 225. When the outer diameter of the inserted end 204 aor 204 b exceeds the inner diameter of the second tapered portion 254,the prongs 255 cantilever slightly outward until the projections 260snap into place to engage the locking section 210 or 226, at which pointthe coupling device 250 is locked in place by a lip 216 or 227. At thispoint, the tip 206 engages the recess 262 formed in the coupling device250. Alternatively, the end of the conical tip 225 engages the recess262. The ability to attach the handle 212 or the coupling device 250 toeither end 204 a or 204 b of the malleable member 202 enables thetunneling device 200 to be used for either outside in or inside outprocedures.

While the present invention is described in connection with what ispresently considered to be the most practical and preferred embodiments,it should be appreciated that the invention is not limited to thedisclosed embodiments, and is intended to cover various modificationsand equivalent arrangements included within the spirit and scope of theclaims. Modifications and variations in the present invention may bemade without departing from the novel aspects of the invention asdefined in the claims, and this application is limited only by the scopeof the claims.

1. A tunneling device for creating a pathway in subcutaneous tissue of aperson's body, said tunneling device comprising: a member having twoends, each of said ends defining an insertion surface that facilitatesthe insertion of the ends into the subcutaneous tissue of the person'sbody; and an interchangeable handle connectable to each of said ends,said handle defining a grasping surface and an opening, said openingconfigured to receive either of said ends, said grasping surfaceenabling a user to securely hold the handle with one hand to forciblymove said member through the subcutaneous tissue of the person's body tocreate the pathway in the subcutaneous tissue, and enabling the user topull a cable of an implant device through the created pathway.
 2. Thetunneling device of claim 1, which includes a tip removably connected toat least one of said ends, said tip defining said insertion surface. 3.The tunneling device of claim 1, which includes a tip removablyconnected to each of said ends, said tips respectively defining saidinsertion surface, wherein at least a portion of each of said endsdefines a plurality of threads, and wherein each of said tips isthreadingly engaged with one of said ends of said member.
 4. Thetunneling device of claim 1, wherein said insertion surface defined byat least one of said ends is a tapered surface.
 5. The tunneling deviceof claim 1, wherein said insertion surface defined by each of said endsis a tapered surface.
 6. The tunneling device of claim 1, which includesa coupler removably connected to one of said ends of said member, saidcoupler adapted to couple said member to an end of said cable.
 7. Thetunneling device of claim 1, wherein the handle includes an actuator,said actuator operable to cause the handle to engage with or disengagefrom one of said ends.
 8. The tunneling device of claim 7, wherein saidhandle includes a shaft and a spring positioned between said shaft andsaid actuator, wherein said actuator is operable to compress said springand cause said shaft to move to a position wherein one of said ends ofsaid member is insertable into or releasable from said handle.
 9. Atunneling system for creating a pathway in subcutaneous tissue of aperson's body, said tunneling system comprising: a malleable memberhaving a first end and a second end, each of said ends defining aninsertion surface that facilitates the insertion of the first and secondends into the subcutaneous tissue of the person's body; aninterchangeable handle connectable to each of said first and secondends, said handle defining a grasping surface and an opening, saidopening configured to receive either of said first and second ends, saidgrasping surface enabling a user to securely hold the handle with onehand; and a coupler operable to join one of said first and second endsof said malleable member and an end of a cable of an implant device tosecure said malleable member and said cable together, said handleoperable to enable a user to forcibly move said malleable member throughthe subcutaneous tissue of the person's body to create the pathway inthe subcutaneous tissue, and enable the user to pull the cable of theimplant device through the created pathway.
 10. The system of claim 9,wherein said handle includes a post and a spring positioned between saidpost and said actuator, said post having a first diameter and a secondsmaller diameter, said post initially positioned adjacent to said firstend of said malleable member inserted in said handle to prevent saidfirst end from being removed from said handle, and said spring biasingsaid post inwardly to cause said second diameter of said post to bepositioned adjacent to said first end of said malleable member to enablesaid first end of said malleable member to be removed from said handle.11. The system of claim 9, wherein said insertion surface of at leastone of said first and second ends is a tapered surface.
 12. The systemof claim 9, wherein said insertion surface of each of said first andsecond ends is a tapered surface.
 13. The system of claim 9, whichincludes a removable tip attached to each of said first and second ends,said removable tips respectively defining said insertion surface. 14.The system of claim 13, wherein said insertion surface of at least oneof said tips is a tapered surface.
 15. The system of claim 13, whereinsaid insertion surface of each of said tips is a tapered surface. 16.The system of claim 13, wherein at least a portion of each of said tipsdefines a plurality of threads, and wherein each of said tips arethreadingly engaged with one of said ends of said malleable member. 17.The system of claim 9, wherein said coupler includes a plurality ofconnectors, a first connector of said plurality of connectors operableto secure said coupler to said end of said cable and a second connectorof said plurality of connectors operable to secure one of said first andsecond ends of said malleable member to said coupler.
 18. A method offorming a pathway in subcutaneous tissue of a person's body, said methodcomprising: (a) providing a member having two ends, each of said endsbeing insertable into the subcutaneous tissue of the person's body; (b)providing a handle connectable to each of said ends of said member, saidhandle including an actuator operable to cause the handle to be engagedwith and disengaged from one of said ends of said member; (c) activatingsaid actuator; (d) connecting said handle to one of said ends of saidmember; (e) inserting the other of said ends into the subcutaneoustissue of the person's body; (f) moving said other of said ends throughthe subcutaneous tissue of the person's body to create the pathway inthe tissue of the body; (g) connecting a cable of an medical deviceimplanted in the body to said other of said ends; and (h) moving saidcable through the pathway created in the body using said handle.
 19. Themethod of claim 18, which includes connecting a coupler to one of saidends of said member and to an end of said cable.
 20. The method of claim18, which includes connecting a removable tip to each of said ends, eachof said removable tips defining an insertion surface to facilitate themovement of the tips through the subcutaneous tissue of the body.
 21. Atunneling device comprising: a malleable member having two ends, one ofsaid ends defining an insertion element for creating a subcutaneouspassage within a person's body, the other of said ends having anengagement surface, said member having alternating gripping and bendablesections along its longitudinal axis; a handle non-rotatably andreleasably connectable to each of said ends, said handle defining agrasping surface and an opening, said opening configured to receiveeither of said ends; and a cable coupler non-releasably engageable withsaid engagement surface, whereby an electrical cable fixed to said cablecoupler may be moved through said passage.
 22. The tunneling device ofclaim 21, said gripping and bendable portions being of differentdiameters.
 23. The tunneling device of claim 21, where said opening ofsaid handle is shaped so that when either of said ends is inserted insaid opening, the member turns in unison with the handle.
 24. Thetunneling device of claim 23, wherein the shape of said opening isoblong.
 25. The tunneling device of claim 22, wherein the diameter ofeach of said gripping sections is larger than the diameter of each ofsaid bendable sections.
 26. The tunneling device of claim 21, in whichsaid cable coupler is adapted to couple said member to an end of saidelectrical cable, said coupler comprising projections formed along aninner surface, said projections being adapted to engage a groove formedin said engagement surface thereby to fix said cable coupler to saidengagement surface.
 27. The tunneling device of claim 21, in which saidengagement surface and said insertion element are integral with saidmalleable member.
 28. The tunneling device of claim 27, in which saidtunneling device is formed of aluminum.
 29. The tunneling device ofclaim 27, in which said tunneling device is formed of a biocompatiblematerial.